Escitalopram for Anxiety
(PrEcISE Trial)
Trial Summary
What is the purpose of this trial?
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.
Will I have to stop taking my current medications?
The trial requires that participants have not been treated with SSRIs (a type of antidepressant) within 12 weeks of starting the study and not be on any medication with psychiatric effects that need more than 5 half-lives to clear from the body. If you're on such medications, you may need to stop them before joining the trial.
What data supports the effectiveness of the drug escitalopram for anxiety?
Research shows that escitalopram is effective in treating various anxiety disorders, including generalized anxiety disorder, social anxiety disorder, and panic disorder. It is well-tolerated and often works faster than similar drugs like citalopram, making it a good option for managing anxiety.12345
Is escitalopram generally safe for humans?
How does the drug escitalopram differ from other treatments for anxiety?
Escitalopram is unique because it is the most selective SSRI (selective serotonin reuptake inhibitor) available, which means it specifically targets serotonin levels in the brain to help reduce anxiety. It is effective for a broad range of anxiety disorders and is well-tolerated, offering advantages over other treatments like benzodiazepines, which can have more side effects.1491011
Research Team
Jeffrey R Strawn, MD, FAACAP
Principal Investigator
University of Cincinnati
Laura B Ramsey, PhD
Principal Investigator
Children's Mercy Kansas City
Eligibility Criteria
This trial is for youths aged 12-17 with generalized, social, or separation anxiety disorder. They must have a certain severity of anxiety, no recent psychotherapy initiation, and be English-speaking. Participants need normal physical exams and EKGs, not be pregnant or drug-positive, and use reliable contraception if sexually active.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard or pharmacogenetically-guided escitalopram dosing for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Escitalopram
Escitalopram is already approved in United States, European Union, Canada for the following indications:
- Major depressive disorder
- Generalized anxiety disorder
- Major depressive episodes
- Generalized anxiety disorder
- Social anxiety disorder
- Panic disorder with or without agoraphobia
- Obsessive-compulsive disorder
- Major depressive disorder
- Generalized anxiety disorder
- Social anxiety disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Cincinnati
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator